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Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Traumatic Brain Injury
Mild Traumatic Brain Injury
Amnestic Mild Cognitive Impairment

Treatments

Device: High Definition Transcranial Direct Current Stimulation
Device: Sham HD-tDCS

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04504630
CDMRP-AZ190088 (Other Grant/Funding Number)
STU-2019-1769

Details and patient eligibility

About

The study will examine the efficacy of high definition transcranial direct current stimulation (HD-tDCS) and its influence on episodic memory in patients with amnestic mild cognitive impairment and a history of Traumatic brain injury. Ten sessions of HD-tDCS to the dorsal anterior cingulate region is expected to result in improvements in episodic memory measures immediately following the last session and at a 3-month follow-up.

Enrollment

26 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 50 and older
  • Native English speakers
  • 12 years of education or higher
  • Active diagnosis of aMCI
  • History of TBI based on VA/DOD criteria

Exclusion criteria

  • TBI within the past 2 years
  • Lifetime history of stroke, transient ischemic attack, heart attack, or congestive heart failure
  • Lifetime history of epilepsy
  • Major psychiatric disorders (i.e., posttraumatic stress disorder, bipolar disorder, schizophrenia)
  • Substance use disorder
  • Has metal fragments in head
  • Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

26 participants in 2 patient groups

Active HD-tDCS
Active Comparator group
Description:
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.
Treatment:
Device: High Definition Transcranial Direct Current Stimulation
Sham HD-tDCS
Sham Comparator group
Description:
Participants will receive 10 sessions of sham stimulation across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.
Treatment:
Device: Sham HD-tDCS

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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